(197 days)
Dynamic TiBase abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
Compatible Implant Systems:
| Compatible Implant System (Connection) | Implant Body Diameter, mm | Implant Platform, mm |
|---|---|---|
| Osstem® TS Hiossen® ET (Internal Taper) | 3.5 | Mini |
| 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 | Regular | |
| Neodent GM (Morse taper) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | GM |
| Nobel Active (Conical Connection) | 3.5 | NP |
| 4.3, 5.0 | RP | |
| 5.5 | WP | |
| Straumann Bone Level (CrossFit® Morse Taper) | 3.3 | NC |
| 4.1, 4.8 | RC | |
| Straumann BLX (TorcFit™ Internal Hexalobular) | 3.5, 3.75, 4.0, 4.5 | RB |
| 5.0, 5.5, 6.5 | WB |
All digitally designed custom abutments for use with Dynamic TiBase abutments are to be sent to a Talladium Medical validated milling center for manufacture.
Dynamic TiBase abutments are two-piece abutments composed of a CAD-CAM fabricated zirconia superstructure and a prefabricated titanium base component where the final two-piece abutment (base and cemented superstructure) is the finished device used for the prosthetic restoration. All subject device bases are made of titanium alloy (Ti-6Al-4V) conforming to ISO 5832-3 and ASTM F136. The Dynamic TiBase abutments are provided in engaging and non-engaging designs for single-unit and multi-unit restorations, respectively.
For each of the compatible OEM implant lines, the prefabricated titanium base components are provided with a gingival height (in the titanium base) ranging from 0.3 mm to 4 mm, and a platform diameter ranging from 4.30 mm to 5.50 mm. Angulation and additional gingival height may be provided in the zirconia superstructure. All Dynamic TiBase prefabricated titanium base components have a post with a cut-out to accommodate a restoration with an angled channel for screw access when clinically necessary. The post height of the prefabricated titanium base component ranges from 3.8 mm to 5.40 mm, and from 2.3 mm to 3.8 mm (cut-out height). The cementable post height of the final patient-matched abutment design, measured above the total combined gingival collar, shall be no less than 4 mm.
All zirconia superstructures (copings) used to complete the final two-piece subject device Dynamic TiBase abutment will be made at a Talladium España, SL validated milling center under FDA quality system regulations, and the material will conform to ISO 13356.
The design parameters for the CAD-CAM zirconia superstructure for the Dynamic TiBase vary slightly among the compatible OEM implants. The design parameters for the CAD-CAM zirconia superstructure are summarized in the following table:
| Implant Compatibility (1) | Minimum Wall Thickness, mm | Maximum Gingival Height, mm | Minimum Gingival Height (2), mm | Maximum Angulation |
|---|---|---|---|---|
| Osstem® TS Hiossen® ET (Internal Taper) | 0.32 | 5.18 | 1.2 | 25º |
| Neodent GM (Morse taper) | 0.32 | 5.20 | 1.2 | 30º |
| Nobel Active (Conical Connection) | 0.35 | 6.20 | 0.30 | 0º |
| Straumann Bone Level (CrossFit® Morse Taper) | 0.32 | 5.18 | 1.1 | 30º |
| Straumann BLX (TorcFit™ Internal Hexalobular) | 0.32 | 5.34 | 1.5 | 30º |
(1) for the compatible sizes shown in Table 1
(2) minimum gingival height in the titanium base, not the zirconia superstructure
The required cement for bonding the zirconia superstructure to the Dynamic TiBases to create the final two-piece abutment is Nova Resin Cement cleared in K213609.
Also, the subject of this submission are seven (7) abutment screws for use with the subject abutments.
This FDA 510(k) clearance letter pertains to a dental implant abutment — the Dynamic TiBase — not an AI-powered diagnostic device or software. Therefore, the information typically requested about acceptance criteria and study designs for validating AI/ML-based medical devices (such as sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable to this document.
The "performance data" section in this 510(k) summary refers to traditional engineering and biocompatibility testing for a physical medical device, not performance metrics for an algorithm.
Here's how to interpret the provided document in the context of "acceptance criteria" and "proof":
Acceptance Criteria and Reported Device Performance (as inferred for a physical device):
For a physical device like the Dynamic TiBase, the "acceptance criteria" are generally met through demonstrating substantial equivalence to a previously cleared predicate device. This involves validating material properties, manufacturing processes, functional performance (e.g., mechanical strength, compatibility), and biocompatibility.
The "study that proves the device meets the acceptance criteria" refers to the non-clinical testing performed to demonstrate substantial equivalence.
| Acceptance Criterion (Inferred for a Dental Abutment) | Reported Device Performance / Proof |
|---|---|
| Biocompatibility (Device materials are safe for biological contact) | Referenced from K232151 (provided in K212108): Biocompatibility testing according to ISO 10993-5 (cytotoxicity) for abutment materials ASTM F136 (titanium alloy) and ISO 13356 (zirconia). This indicates the materials did not show cytotoxic effects when tested according to the standard. |
| Mechanical Performance/Strength (Abutment can withstand oral forces without failure) | Provided in this submission: Mechanical testing conducted according to ISO 14801 to support the performance of the subject device abutments in conjunction with the compatible OEM implants. This standard specifically evaluates the fatigue strength of endosseous dental implants. The successful completion of this testing, validated against the predicate device, implies the device meets required load-bearing capacities. |
| MRI Safety (Device does not pose undue risk in MRI environment) | Provided in this submission: Non-clinical worst-case MRI review to evaluate subject device components in the MR environment using scientific rationale and published literature. This included addressing magnetically induced displacement force and torque parameters as per FDA guidance. The review concluded that the device is safe for MRI under specified conditions. |
| Sterilization Efficacy (Device supplied non-sterile can be effectively sterilized by user) | Referenced from K232151 (provided in K212108): Moist heat sterilization validated to a sterility assurance level (SAL) of 10-6 by the overkill method according to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO TIR 17665-2. This demonstrates that the specified sterilization method for end-users achieves the required sterility. |
| Dimensional Compatibility & Fit (Device correctly interfaces with specified implants) | Provided in this submission: Reverse engineering dimensional analysis (of OEM implant bodies, OEM abutments, and OEM abutment screws) to demonstrate that the subject device abutments are compatible with listed OEM Implant Systems (Osstem® TS/ Hiossen® ET, Neodent GM, NobelActive, Straumann Bone Level, and Straumann BLX Implant Systems). This confirms the physical design correctly matches the intended implant systems. |
| Material Conformance (Materials meet specified standards) | Materials confirmed to conform to: Ti-6Al-4V (ASTM F136, ISO 5832-3) for titanium components; Zirconia (ISO 13356) for superstructure; Nova Resin Cement (cleared in K213609) for bonding. This demonstrates the use of medical-grade, standard-compliant materials. |
| Manufacturing Quality (Device is produced under controlled conditions) | Stated that zirconia superstructures will be made at a Talladium España, SL validated milling center under FDA quality system regulations. This implies adherence to Good Manufacturing Practices (GMP). |
Regarding the specific questions about an AI/ML context:
- A table of acceptance criteria and the reported device performance: Provided above, adapted for a physical medical device.
- Sample size used for the test set and the data provenance: Not applicable. The "test set" for this physical device refers to the number of physical abutment samples or material samples subjected to mechanical, biocompatibility, and MRI testing. The document does not specify exact sample numbers for these engineering tests, only the standards used (e.g., ISO 14801 typically specifies minimum sample sizes). Data provenance is "non-clinical data" generated from laboratory testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a dental abutment's performance is established by engineering standards, material specifications, and physical testing, not by expert human interpretation of images or clinical outcomes in the same way as an AI diagnostic.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is a concept used in evaluating human reader performance in AI studies.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for AI-assisted diagnostic devices.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to an AI algorithm's performance.
- The type of ground truth used: For a physical device, "ground truth" is defined by adherence to established engineering standards (e.g., ISO 14801 for mechanical strength), material properties, and biocompatibility standards. "Reverse engineering dimensional analysis" served as a form of "ground truth" for compatibility. No pathology or outcomes data was used for this premarket notification.
- The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) clearance is for a physical medical device (dental abutment), and the "performance data" section details the engineering and material testing conducted to demonstrate its safety and effectiveness, primarily through substantial equivalence to previously cleared devices. It does not involve AI/ML validation methodologies.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)